Pfizer abandons the development of danuglipron, an experimental oral GLP-1 receptor agonist being evaluated for chronic weight management, due to safe...
FDA seizes several hundred units of counterfeit Ozempic (semaglutide) 1mg injection that had entered the U.S. drug supply chain.
Vanda Pharmaceuticals sues FDA seeking a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon)...
Former CBER director Peter Marks tells Time that he was seeing an increasing anti-vaccine tone before he resigned from the agency over pressure from t...
FDA approves an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) f...
FDA grants Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA vaccine candidate, ARCT-2304, for protecting against H5N1 influ...
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) and Yervoy (ipilimumab) for combination first-line treatment of adult patients with unresectable...
U.S. senator Rand Paul (R-KY) introduces legislation to streamline the approval process for biosimilars by eliminating costly and redundant clinical s...
